Dear Fellow Shareholders,

The third quarter of 2026 marked another important period of progress for Aclarion as we continued executing our strategy to transform the evaluation of chronic low back pain. Building upon our first-half momentum, we delivered strong commercial growth, expanded our clinical trial network, strengthened our intellectual property portfolio, and advanced the clinical evidence supporting broader adoption of Nociscan®.

Third Quarter 2026 Highlights

• Nociscan scan volumes increased 85% compared with the third quarter of 2025, demonstrating continued commercial momentum and growing physician utilization.
• Our clinical evidence foundation was further strengthened by the October 15 publication of a peer-reviewed article in the European Spine Journal, highlighting the potential for magnetic resonance spectroscopy (MRS) to become a viable alternative to provocative discography (PD).
• We also expanded the CLARITY randomized clinical trial to eleven clinical sites and implemented revised enrollment criteria designed to accelerate recruitment and strengthen the study's real-world relevance.

• With the overall CLARITY trial duration remaining on track, we look forward to providing an update on enrollment progress and anticipated timeline for the initial readout by year‑end.

• Importantly, we ended the quarter with $14.2 million in cash, providing an anticipated runway into the second half of 2027 and the resources to fully fund our 300-patient CLARITY trial.

Together, these developments reinforce our progress across three strategic priorities: commercial adoption, clinical evidence, and reimbursement access.

Commercial Momentum: Continued Strong Growth

Third-quarter Nociscan scan volumes increased 85% year-over-year, reflecting continued commercial traction and contributing to 117% growth in total scan volumes for the nine months ended September 30, 2026 compared to the same period in 2025, and 86% sequential growth compared to the nine months ended December 31, 2025.

We believe this performance reflects increasing physician recognition of the value of objective biochemical insights in evaluating chronic low back pain.

During the quarter, we expanded our commercial footprint with Goodman Campbell Brain & Spine, establishing the first practice in Indiana to offer Nociscan.

Our commercial strategy remains focused on expanding physician access while increasing utilization among existing customers. Combined with our cloud-based, software-native platform, which avoids the manufacturing and inventory requirements of traditional medical devices, we believe this approach provides a foundation for highly profitable and scalable growth.

Clinical Evidence: Independent Research Supports Our Vision

One of our most significant recent accomplishments was the October 15 publication of “Lumbar Spectroscopy in the Diagnosis of Lumbar Discogenic Pain” in the peer-reviewed European Spine Journal.

The study authors compared the non-invasive Nociscan to invasive discography in twenty consecutive patients being evaluated for surgical treatment, across 55 lumbar discs. Nociscan findings successfully identified painful discs, agreeing with discography in up to 87% of discs under a moderate threshold.

The authors concluded:

“MRS of lumbar discs may become a viable alternative to PD, as our experience and technique evolves.”

We believe this conclusion is particularly meaningful. Provocative discography (PD) has historically been used to identify painful lumbar discs, but its invasive nature and clinical limitations create a need for alternative approaches.

The possibility that MRS could become a viable alternative reinforces our vision of making objective biochemical information a routine component of spine care decision-making.

This publication adds to our growing body of peer-reviewed research, strengthening the scientific foundation for physician adoption, reimbursement discussions, and broader clinical acceptance of Nociscan.

Read the European Spine Journal publication

CLARITY: Accelerating Enrollment and Strengthening Clinical Relevance

During the third quarter, we expanded our CLARITY clinical trial network to eleven participating sites, including the University of Arizona College of Medicine – Phoenix and NYU Langone Health.

CLARITY is our prospective, randomized, 300-patient trial designed to evaluate whether incorporating Nociscan's biochemical insights into surgical planning improves outcomes for patients with discogenic chronic low back pain.

In early October, we announced revised inclusion and exclusion criteria designed to accelerate enrollment while maintaining scientific rigor.

The original criteria were highly selective to minimize confounding factors. However, experience across participating sites demonstrated that they excluded many patients that spine surgeons routinely evaluate and treat.

Working with our principal investigator and participating surgeons, we refined the criteria to expand the eligible patient population and better reflect real-world clinical practice.

The revised criteria have received Institutional Review Board approval at nine of our eleven active sites, with the remaining two sites screening patients under the updated criteria while awaiting local approval.

Although enrollment under the original criteria progressed more slowly than anticipated, we expect these changes to meaningfully improve recruitment. We plan to update shareholders on enrollment progress and anticipated initial readout timing by year-end.

We do not currently anticipate that these adjustments will extend the overall duration of CLARITY.

Combined with our growing portfolio of peer-reviewed publications, we believe CLARITY will provide critical evidence to support broader physician adoption and expanded reimbursement.

Reimbursement: Expanding Patient Access

Reimbursement remains essential to achieving widespread Nociscan adoption.

During the first half of 2026, we made meaningful progress in the United Kingdom, where Nociscan has been reimbursed by Vitality, AXA, and Aviva, three of the four largest private insurers.

In the United States, our partnership with PRIA Healthcare established a dedicated Market Access Program to advance payer engagement and pursue insurance coverage.

We believe our expanding clinical evidence, including the recent European Spine Journal publication and CLARITY, will strengthen these initiatives.

Our objective remains to align clinical utility with sustainable reimbursement, making Nociscan accessible to more patients.

Innovation: Strengthening Our Competitive Position

During the third quarter, we received a Notice of Allowance for a patent focused on improving the accuracy and adoption of Nociscan's magnetic resonance spectroscopy scanning process.

This builds upon our first-half intellectual property progress, including a newly issued AI-focused patent and a portfolio totaling 62 issued and pending patents worldwide.

We believe our proprietary technology, expanding clinical evidence, and scalable software delivery model create a differentiated foundation for long-term growth.

Financial Strength: Fully Funded to Execute CLARITY

We ended September 30, 2026, with $14.2 million in cash and cash equivalents, providing a strong financial foundation to advance our strategic priorities.

We believe our current cash position provides funding into the second half of 2027 and fully funds the CLARITY clinical trial, one of the most important value-creating initiatives in our company's history.

This financial strength allows us to focus on commercial expansion, reimbursement advancement, and generating the clinical evidence necessary to drive broader Nociscan adoption.

We remain committed to disciplined capital allocation and investments that strengthen our competitive position and create sustainable shareholder value.

Looking Ahead: Converting Progress into Long-Term Value

As we enter the final quarter of 2026, our priorities remain clear: build upon our 85% year-over-year scan volume growth, expand physician access and utilization, advance reimbursement initiatives, and accelerate CLARITY enrollment under the revised criteria.

We expect to provide shareholders with an update on CLARITY enrollment and anticipated initial readout timing by year-end.

Aclarion is addressing a fundamental limitation in chronic low back pain treatment. Traditional imaging provides anatomical information, but anatomy alone does not always explain the source of pain. Nociscan adds objective biochemical insights that can help physicians better understand which discs may be contributing to a patient's symptoms.

Our vision is to make this biochemical insight a routine component of spine care decision-making.

We remain early in our commercialization journey, but our growing scan volumes, expanding clinical evidence, engagement with leading spine specialists, and financial resources to fully fund CLARITY provide tangible evidence of our progress.

Our focus remains on execution, accountability, and delivering milestones that matter to patients, physicians, and shareholders.

On behalf of the entire Aclarion team, thank you for your continued confidence and support. We look forward to building upon this momentum and creating long-term shareholder value.

Sincerely,

Brent Ness
Chief Executive Officer
Aclarion, Inc.
NASDAQ: ACON